Lower riskMedical device recall · FDA · Published March 28, 2018
RayStation Radiation Therapy Software Recalled for Dose Calculation Inaccuracy
RaySearch Laboratories recalls RayStation versions 6.0-7.0 due to potential dose calculation errors in radiation therapy planning. Users must verify calculations to avoid incorrect treatments.
The dose calculation accuracy may in some situations be less than expected. The user must be aware in order to avoid incorrect dose calculations during treatment planning.
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Contact the company
📍Recalling firmRAYSEARCH LABORATORIES ABSveavagen 9 · Stockholm, Sweden
“RayStation Radiation Therapy Software Recalled for Dose Calculation Inaccuracy.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71600-raystation-radiation-therapy-software-recalled-for-dose-calculation-inaccuracy. Based on FDA recall #Z-2290-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2290-2018%22&limit=1).
The FDA announced on March 28, 2018, that RaySearch Laboratories AB is recalling RayStation Radiation Therapy Treatment Planning System versions 6.0, 6.1, 6.2, and 7.0 because dose calculation accuracy may be less than expected in some situations.
How to tell if you have it
Brand: RaySearch Laboratories
Product: RayStation Radiation Therapy Treatment Planning System
Versions: 6.0, 6.1, 6.2, 7.0
Specific versions: 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7, 7.0.0.19
Units affected: 728
The hazard
The dose calculation accuracy may in some situations be less than expected. The user must be aware in order to avoid incorrect dose calculations during treatment planning.
Context
GovInfoNow's records show RaySearch Laboratories AB has issued 36 other recalls since July 17, 2017. Other recent recalls of similar products include Boston Scientific TheraSphere 360 Y-90 Software Anomaly Recall (June 19, 2026), Elekta Leksell GammaPlan 11.1 Software Recall (Dec. 12, 2025), and Elekta Leksell GammaPlan software version 11.3/11.4 recall (Dec. 12, 2025).
How to tell if you have this one
Check if you own RayStation software versions 6.0, 6.1, 6.2, or 7.0. The software is used by radiation therapy professionals for treatment planning and dose calculations.
Brand
RaySearch Laboratories
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Verify Dose Calculations
Check that dose calculations are accurate before proceeding with treatment planning.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 31 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide Distribution in the states of AL, AR, AZ, CA, CT, DC, DE, FL, GA, HI, ID, IL, MA, MD, ME, MI, MO, MS, MT, NC, NJ, NY, OH, OR, PA, TN, TX, UT, VA, VT, WA, WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Maine, Maryland, Massachusetts, Michigan, Mississippi, Missouri, Montana, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 2.2 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2290-2018 (March 28, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2290-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.